Lamictal ODT 50mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant, Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative, Voltage-gated sodium channel blocker
Pregnancy Category
Category C
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamictal ODT is a medication used to treat certain types of seizures (epilepsy) and to help stabilize mood in people with bipolar disorder. It works by calming overactive electrical signals in the brain. The ODT (Orally Disintegrating Tablet) dissolves quickly in your mouth.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. To take the medication:
Place the tablet on your tongue and let it dissolve completely. You don't need to drink water with it.
Do not swallow the tablet whole, chew it, break it, or crush it.
Important Warnings
Do not change your dose or stop taking this medication without talking to your doctor first. Stopping the medication abruptly can increase the risk of seizures. If you need to stop taking the medication, your doctor will instruct you on how to gradually reduce the dose to minimize potential side effects.
If you've stopped taking the medication and need to restart it, consult with your doctor. You may need to begin with a lower dose and gradually increase it as directed by your doctor.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom.
Keep all medications out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. To take the medication:
Place the tablet on your tongue and let it dissolve completely. You don't need to drink water with it.
Do not swallow the tablet whole, chew it, break it, or crush it.
Important Warnings
Do not change your dose or stop taking this medication without talking to your doctor first. Stopping the medication abruptly can increase the risk of seizures. If you need to stop taking the medication, your doctor will instruct you on how to gradually reduce the dose to minimize potential side effects.
If you've stopped taking the medication and need to restart it, consult with your doctor. You may need to begin with a lower dose and gradually increase it as directed by your doctor.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom.
Keep all medications out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed; do not stop taking it suddenly without consulting your doctor, as this can cause seizures to worsen.
- Report any new skin rash immediately to your doctor, as it could be a sign of a serious reaction.
- Avoid alcohol or other CNS depressants, as they can increase drowsiness and dizziness.
- Be aware that this medication can cause dizziness or drowsiness, so avoid driving or operating machinery until you know how it affects you.
- If you are a woman of childbearing potential, discuss contraception and pregnancy planning with your doctor.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable, requires slow titration based on concomitant medications and indication. For epilepsy monotherapy: Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50 mg/day every 1-2 weeks. Maintenance 300-500 mg/day in 1-2 divided doses. For bipolar I disorder: Initial 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then 100 mg once daily for 1 week, then 200 mg once daily. Maintenance 200 mg/day.
Dose Range:
25 - 700 mg
Condition-Specific Dosing:
Concomitant Valproate:
Initial 25 mg every other day for 2 weeks, then 25 mg once daily for 2 weeks, then 50 mg once daily for 1 week. Maintenance 100-200 mg/day.
Concomitant Enzyme Inducers (e.g., Carbamazepine, Phenytoin, Phenobarbital, Primidone):
Initial 50 mg once daily for 2 weeks, then 100 mg/day in 2 divided doses for 2 weeks, then increase by 100 mg/day every 1-2 weeks. Maintenance 300-500 mg/day in 2 divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for general use. Limited data for Lennox-Gastaut syndrome in infants >2 years.
Child:
Dosing is weight-based and depends on concomitant medications. For epilepsy (Lennox-Gastaut, partial seizures, generalized tonic-clonic) in children 2-12 years: Initial doses range from 0.3 mg/kg/day to 2 mg/kg/day depending on concomitant medications, titrated slowly over several weeks. Maintenance doses range from 1-15 mg/kg/day.
Adolescent:
Dosing generally follows adult guidelines, especially for those >12 years, but may require careful titration based on weight and concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Consider lower maintenance doses.
Severe:
Consider lower maintenance doses (e.g., 25% reduction).
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25%.
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50%. Further reductions may be needed based on clinical response.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and modulating the release of excitatory neurotransmitters (e.g., glutamate and aspartate). It is thought to act at presynaptic membranes to prevent the release of these neurotransmitters, which are implicated in the generation of epileptic seizures and mood disorders.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral tablets); ODT may be slightly faster.
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
0.97 to 1.22 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly affected by concomitant medications (e.g., reduced to 13-14 hours with enzyme inducers, increased to 59-70 hours with valproate).
Clearance:
Approximately 0.3 mL/min/kg (monotherapy)
ExcretionRoute:
Urine (approximately 94%), Feces (approximately 2%)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration required to minimize rash risk)
PeakEffect:
Weeks (after reaching maintenance dose)
DurationOfAction:
24 hours (allows for once or twice daily dosing)
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The incidence of these rashes, which have resulted in death, is approximately 0.3% to 0.8% in pediatric patients (2 to 16 years of age) and 0.08% to 0.3% in adults. Risk factors include concomitant use of valproate, exceeding recommended initial doses, and rapid dose escalation. Aseptic Meningitis: Cases of aseptic meningitis have been reported. Hemophagocytic Lymphohistiocytosis (HLH): Cases of HLH, a severe, life-threatening immune reaction, have been reported.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking
Other Side Effects
Most people taking this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, including:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
In rare cases, this medication can cause a life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking
Other Side Effects
Most people taking this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, including:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash (especially red spots, blisters, or peeling skin)
- Fever, swollen glands, or facial swelling
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- Worsening seizures
- New or worsening depression, anxiety, or agitation
- Thoughts of self-harm or suicide
- Unusual changes in behavior or mood
- Stiff neck, headache, nausea, vomiting, sensitivity to light (signs of aseptic meningitis)
- Persistent fever, enlarged liver/spleen, swollen lymph nodes, unusual bleeding/bruising, extreme fatigue (signs of HLH)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
Additionally, to ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
Additionally, to ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the medication.
Monitoring and Lab Tests
Regular blood work is necessary to monitor your condition. Follow your doctor's instructions for lab tests, and inform all healthcare providers and lab workers that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances may interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. If you experience new or worsening symptoms such as depression, anxiety, restlessness, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult your pharmacist.
Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in pediatric patients.
Birth Control and Hormone-Based Therapies
If you are taking birth control pills or other hormone-based therapies, inform your doctor, as these medications may interact with your treatment. The effectiveness of birth control pills may be reduced, and the risk of side effects may increase during the week when the pills are not active. Consider using alternative birth control methods, such as condoms, to prevent pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult your doctor to adjust your treatment plan as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the medication.
Monitoring and Lab Tests
Regular blood work is necessary to monitor your condition. Follow your doctor's instructions for lab tests, and inform all healthcare providers and lab workers that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances may interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. If you experience new or worsening symptoms such as depression, anxiety, restlessness, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult your pharmacist.
Heart Problems
If you have an abnormal heartbeat, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in pediatric patients.
Birth Control and Hormone-Based Therapies
If you are taking birth control pills or other hormone-based therapies, inform your doctor, as these medications may interact with your treatment. The effectiveness of birth control pills may be reduced, and the risk of side effects may increase during the week when the pills are not active. Consider using alternative birth control methods, such as condoms, to prevent pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult your doctor to adjust your treatment plan as needed.
Overdose Information
Overdose Symptoms:
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Increased seizures
- Decreased consciousness
- Coma
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US).
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels, increases risk of serious rash)
- Carbamazepine (decreases lamotrigine levels)
- Phenytoin (decreases lamotrigine levels)
- Phenobarbital (decreases lamotrigine levels)
- Primidone (decreases lamotrigine levels)
- Oral Contraceptives containing estrogen (decreases lamotrigine levels)
- Rifampin (decreases lamotrigine levels)
Moderate Interactions
- Lopinavir/Ritonavir (decreases lamotrigine levels)
- Atazanavir/Ritonavir (decreases lamotrigine levels)
- Ethinyl estradiol/Norgestimate (decreases lamotrigine levels)
- Paracetamol/Acetaminophen (may slightly decrease lamotrigine levels with chronic high doses)
Minor Interactions
- Sertraline (may slightly decrease lamotrigine levels)
- Bupropion (may slightly decrease lamotrigine levels)
Monitoring
Baseline Monitoring
Baseline seizure frequency/mood symptoms
Rationale: To establish efficacy baseline and monitor treatment response.
Timing: Prior to initiation
Renal and Hepatic function tests (e.g., BUN, creatinine, ALT, AST, bilirubin)
Rationale: To guide initial dosing adjustments in patients with pre-existing impairment.
Timing: Prior to initiation, if impairment is suspected
Routine Monitoring
Skin for rash (especially within the first 8 weeks)
Frequency: Daily during titration, then regularly
Target: Absence of rash
Action Threshold: Any new rash, especially if accompanied by fever, facial swelling, lymphadenopathy, or mucosal involvement, requires immediate discontinuation and medical evaluation.
Seizure frequency/severity or mood stability
Frequency: Regularly (e.g., weekly during titration, then monthly/quarterly)
Target: Reduction in seizure frequency/severity or stabilization of mood symptoms
Action Threshold: Worsening of symptoms, lack of efficacy, or intolerable side effects.
Signs of hypersensitivity syndrome (DRESS), aseptic meningitis, or HLH
Frequency: Regularly, especially during initial treatment
Target: Absence of symptoms
Action Threshold: Fever, lymphadenopathy, facial edema, liver dysfunction, unexplained rash, stiff neck, headache, photophobia, nausea/vomiting, prolonged fever, hepatosplenomegaly, lymphadenopathy, cytopenias, hyperferritinemia.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial treatment and dose changes
Target: Absence of suicidal thoughts or behaviors
Action Threshold: Any new or worsening suicidal thoughts or behaviors.
Symptom Monitoring
- Skin rash (red spots, blisters, peeling skin)
- Fever
- Swollen glands (lymphadenopathy)
- Swelling of the face, eyes, or lips
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain
- Worsening seizures
- New or worsening depression, anxiety, or agitation
- Thoughts of self-harm or suicide
- Unusual changes in behavior or mood
- Stiff neck, headache, nausea, vomiting, sensitivity to light (signs of aseptic meningitis)
- Persistent fever, enlarged liver/spleen, swollen lymph nodes, unusual bleeding/bruising, extreme fatigue (signs of HLH)
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While older classifications placed it as Category C, newer data from pregnancy registries suggest that the risk of major congenital malformations may not be significantly increased compared to the general population, though a slight increase in oral clefts has been observed in some studies. Use during pregnancy should be carefully weighed against the risks of untreated epilepsy or bipolar disorder. Folic acid supplementation is recommended for women of childbearing potential.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (cleft lip/palate), though data are conflicting and overall risk is low.
Second Trimester:
Generally considered lower risk for malformations compared to first trimester.
Third Trimester:
No specific increased risk of malformations. Potential for withdrawal symptoms in neonates if discontinued abruptly before delivery.
Lactation
Lamotrigine is excreted into breast milk. The amount varies, but infant serum levels can be significant. Monitor breastfed infants for adverse effects such as rash, sedation, poor feeding, and weight gain. Breastfeeding may be considered with careful monitoring of the infant.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for rash, sedation, poor feeding, and weight gain. Consult with a healthcare provider.
Pediatric Use
Approved for certain seizure types (Lennox-Gastaut syndrome, partial seizures, generalized tonic-clonic seizures) in children 2 years and older. Dosing is complex, weight-based, and highly dependent on concomitant medications. The risk of serious rash is higher in pediatric patients (0.3% to 0.8%) compared to adults.
Geriatric Use
Start with lower doses and titrate slowly due to potential for decreased renal/hepatic function and increased sensitivity to adverse effects. Monitor for dizziness, ataxia, and other CNS side effects.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes (SJS/TEN). Adherence to the titration schedule is paramount.
- Concomitant medications, especially valproate (inhibits lamotrigine metabolism) and enzyme-inducing AEDs (induce lamotrigine metabolism), significantly impact lamotrigine dosing and require specific titration schedules.
- Patients must be educated to report any new rash immediately and discontinue the medication if a rash develops, unless otherwise instructed by a healthcare professional.
- Lamotrigine ODT can be dispersed in a small amount of water or chewed and swallowed, offering flexibility for patients who have difficulty swallowing tablets.
- While therapeutic drug monitoring (TDM) is not routinely required, it can be useful in cases of suspected toxicity, lack of efficacy, or significant drug interactions.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Valproate, Topiramate, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin.
- For Bipolar I Disorder (Mood Stabilization): Lithium, Valproate, Carbamazepine, Atypical Antipsychotics (e.g., Olanzapine, Quetiapine, Aripiprazole).
Cost & Coverage
Average Cost:
$50 - $200 per 30 tablets (generic 50mg ODT)
Generic Available:
Yes
Insurance Coverage:
Generic: Tier 1 or 2; Brand: Tier 3 or 4
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.